Surgical instrument for conization of uterine cervix



Dec. 12, 1967 c. CREELMAN 3,

SURGICAL INSTRUMENT FOR CUNIZATION O1" UTERINE CERVIX 3 Sheets-Sheet 1 Filed Jan. 6, 1967 INVENTOR.

RAYMOND CREELMAN ATTORNEYS Dec. 12, 1967 R. c. CREELMAN SURGICAL INSTRUMENT F OR CONIZATION OF UTERINE CERVIX 3 Sheets-Sheet 2 Filed 'Jan. 6, 1967 INVENTOR. RAYMOND CREELMAN ATTORNEYS SURGICAL INSTRUMENT FOR CONIZATION OF UTERINE CERVIX 3 Sheets-Sheet Filed Jan. 6, 1967 MN\ 3Q 30 MMWWWWMWWMWWM W WM MHMMHm kij n W i l h. H H H I1 l I H P: [I

4 TTOR/YEKS' United States Patent 3,357,422 SURGICAL INSTRUMENT FOR CONIZATIO 0F UTERINE CERVIX Raymond C. Creelman, 532 th St, Bremerton, Wash. 9831i} Filed .Ian. 6, 1967, Ser. No. 613,984 18 Claims. (Cl. 128-2) ABSTRACT OF THE DISELOSURE This application discloses surgical instruments for the cold-knife removal of a conical section of tissue from the portiovaginalis including the lower extremity of the endocervical canal as in standard biopsy procedure. An elongated pointed blade is mounted for plunging movement on a handle having an obturator secured to one end.

This application is a continuation-in-part of my now abandoned application of the same title, Ser. No. 364,507, filed on May 4, 1964.

The invention is herein illustratively described by reference to the presently preferred embodiments thereof; however, it will be recognized that certain modifications and changes therein with respect to details may be made without departing from the essential features involved.

Cold-knife conization is apparently a simple procedure but in practice is fraught with a high degree of morbidity. In general the biopsy section comprises the lower two to three centimeters of the endocervix. The diiiiculty with use of standard instruments has been primarily due to inability to gauge and control the incision under the conditions of limited working space and visibility, coupled with the mobility and toughness of the uterine cervix. Even with great care it was extremely difficult to cut and remove a precise conical section of tissue with a minimum of trauma and hemorrhage, such as from undercutting the opposite side of the endocervical canal in the process of severing the cone.

An object of this invention, therefore, is to devise a reliable and precisely operable surgical instrument with which to remove a symmetrical cone of tissue which is of controlled and uniform dimensions, without unnecessarily cutting into adjoining tissue or otherwise injuring the uterine cervix.

A related object is to devise such an instrument in which the problems of limited working space and visibility are overcome and which permits the operation to be performed in a very short period of time.

Still another object is to devise an instrument in which sections of tissue of generally standardized selected dimensions may be removed from all patients without regard to condition and in which the dimensions of the cone being removed may be changed by a simple adjustment or blade replacement in the instrument.

Still another object is to devise an instrument of the type described which not only facilitates the establishment and maintenance of operative contact with the cervix, but which facilitates withdrawal of the severed section as the instrument itself is removed upon completion of the operation.

In its preferred forms as herein disclosed the improved surgical instrument comprises an elongated obturator insertable lengthwise into the endocervical canal, stop means in the form of a shoulder or platform physically connected with the obturator in such relative position as to engage the endocervix extremity and thereby limit penetration of the obturator to a controlled depth, an elongated support having a handle end and a distal opposite end, the latter of which carries the obturator to elfect such insertion thereof, and an elongated preferably pointed cutting blade rotatable about the obturator axis and having a circumferentially directed cutting edge. The blade is movably mounted on the support also for plunging movement of the blade generally lengthwise of itself between an inner extended position, pressed through the cervical tissue substantially to the cervical canal (i.e. normally into contact with the side of the obturator as a protective stop), and an outer or retracted position withdrawn laterally from the obturator and out of contact with the cervix. In one embodiment the blade carrier comprises an arm pivoted on the support so as to move the blade in an arcuate path, with provisions for adjusting the effective length of the arm and thereby the radius of the path so as to vary the base dimension of the conical section removed. The blade arm is actuated by a member extending to a convenient point of accessibility at the handle end of the support. As a further feature, the blade is arcuately curved in approximate conformity with its arcuate path of plunging movement so that it encounters minimum resistance and avoids damaging adjacent blood vessels and tissue.

In another embodiment the blade is slidably supported for movement parallel to the handle axis with the obturator being disposed at an angle with respect to the handle axis. The angle can be adjusted in accordance with the desired dimensions of the specimen to be removed. As in the other embodiment, the blade is moved generally lengthwise of itself between an inner position of engagement with the obturator and a retracted position. The blade is also adjustable on the handle to provide for further control over the section dimensions.

These and other features, objects and advantages of the invention will become more fully evident from the following description thereof with reference to the accompanying drawings.

FIGURE 1 is a side view of the instrument as viewed perpendicular to the plane of swing of the blade carrier arm. l

FIGURE 2 is a side view of the instrument taken at right angles to the viewing plane in FIGURE 1.

FIGURE 3 is a longitudinal sectional view of the oper ating end of the instrument at an enlarged scale so as to show certain details of the blade mount, associated support and actuator components.

FIGURE 4 is an end view of the instrument taken on the line 4-4 in FIGURE 1.

FIGURE 5 is a fragmentary side view of the operating end of the instrument at the same scale as the comparable portion thereof in FIGURE 1, but with the blade positioned at a different radius on its carrier arm.

FIGURE 6 is an operating side view showing the instrument in operating position in relation to a uterine cervix.

FIGURE 7 is a perspective view illustrating movements of the blade in successive stages of the operation.

FIGURE 8 is a side view, partially cut away, of a further embodiment of the invention.

FIGURE 9 is a fragmentary top view of the operating end of the instrument of FIGURE 8.

FIGURE 10 is an end and cross-sectional View along lines 10-10 of FIGURE 8.

FIGURE 11 is a side view of the operating end showing by way of dashed lines the manner in which the blade and the obturator are adjusted with respect to the handle.

FIGURE 12 is an operating side view showing the instrument in position.

FIGURE 13 is another operating side view showing the mobile cervix held in a different position by the instrument of FIGURES 8-12.

The instrument shown in FIGURES 1-7 comprises an elongated support having a handle portion 12 ,at one end and at its opposite distal end 14 having a longitudinally projecting positional referencing element comprising the elongated obturator 16 terminating at its base in an annular flange or shoulder 18 which functions as a stop. The smoothly surfaced obturator 16 is designed for insertion into the endocervical canal to .a depth limited by the stop 18 and to permit revolving the instrument about an axis defined by the canal.

A pointed and elongated surgical blade 20 secured by Allen head set screws 22 in the head 24 is mounted on the swinging end of a carrier arm 26. The carrier armis pivotally mounted at 28 on the support terminus 14 so as to swing on an axis transverse to the length of the obturator 16. The are of the blade conforms approximately to its arcuate path of motion on the arm, which path brings the blade into incidence with the side of the obturator 16 at an acute angle (FIGURE 1). The. head 24 is slotted to receive the arm 26 and is secured to the arm by a screw 24a which passes through one of a series of apertures 26a in the arm. The selection of one of the apertures determines the radius of swing of the blade and thereby the base dimension of the conical biopsy section severed from the endocervix. The blade is mounted in the head 24 with the blades cutting edge 20a directed circumferentially with relation to the path of motion thereof generated by revolving of the instrument about the axis of obturator 16, as will subsequently appear. Arcuate curvature of blade 20 in substantial conformity to its longitudinal plunging motion, effected by swinging of the arm forwardly toward the obturator, minimizes resistance of the blade in cutting through the tissue and prevents injuring vessels in the region beyond the zone of incision.

Actuation of the blade in a longitudinal sense is effected by swinging of the. arm 26. Such motion is produced by longitudinal reciprocation of a rod 30 pivotally connected to the arm through a link 36 and guided within the handle portion 12 of support 10. A screw-threaded collar 30a threaded into the inner end of the handle portion 12 serves as a guide for the rod 30 and as a stop for the helical compression spring 32 received within the bore of the handle portion 12 surrounding the rod. A sleeve or enlargement 34 fixed to the outer end of the rod has an enlarged extremity serving as a control knob 34b and an inner portion 34a of reduced diameter slidably received in the handle portion bore and serving as a stop for engagement by spring 32. Compressive force of the spring 32 urges the sleeve 34 and thereby the rod 30 outwardly of the handle in order to maintain the blade normally in its retracted position (FIGURE 3).

In order to perform a cervical conization with this instrument, the surgeon, after appropriate preparatory measures, including the use of a gravity speculum S (FIGURE 6) or other suitable instrument inserts the obturator into the endocervical canal as depicted in FIG- URES 6 and 7. In order to introduce the obturator in this manner it is usually necessary for the surgeon first to grasp the cervix with a tenaculum and draw it downward, whereupon the cervical canal is dilated with Hegar dilators to No. 20F. The surgeon, having introduced the obturator to the point where the shoulder or operating platform 18 is contiguous with the portiovaginalis, is then assured that the cervix is properly oriented and that the instrument is in operating position ready for the making of incisions.

Holding the instrument firmly against the cervix by means of inwardly directed force applied to the handle 12, the surgeon then plunges the pointed blade 20 through the cervical tissue by advancing the knob 34 in relation to handle 12. At the point where the tip of the blade 20 substantially contacts the side of the obturator 16 to complete the plunging incision, the blade head 24 contacts the back side of the flange or shoulder member 18 and arrests the motion positively. The blades projecting length is adjusted so that substantial contact be tween the tip of the blade and the obturator occurs at the positive stopping point. The surgeon thereupon retracts the blade, either positively or by releasing the knob 34 so that the return spring 32 will effect the retraction of the rod 30 out of contact with the cervix, as shown in FIGURES 3 and 7. With the blade thus withdrawn the instrument is rotated incrementally about the obturator axis and the blade again plunged into the cervix tissue to its extended position as shown in FIGURES 1 and 6 to cut an incision substantially contiguously adjacent to or overlapping the first incision. This process is repeated successively until a full circle of plunging incisions has been completed. Thereupon, in order to complete the severance by cutting through any remaining septa, the blade, in its extended position as shown in FIGURES 6 and 1, is rotated in a complete circle by simply revolving the entire instrument about the obturators axis, using the obturator as a supporting shaft and guide. The resultant biopsy cone of portiovaginalis tissue is thereupon removed upon the obturator as the instrument itself is withdrawn. If necessary to hold the severed section on the obturator for removal, the blade may be maintained in its extended position as the instrument is being withdrawn.

In FIGURES 8-13 2. further embodiment of the present invention is illustrated and includes an elongated support 110 having a handle portion 112 at one end thereof. At its opposite distal end 114 the support has. a longitudinally projecting obturator 116 which terminates at its base in an annular flange or shoulder 118. The obturator 116 is provided at its base end with a threaded opening adapted to mate with the stud 105 carried on the connecting element 106 which as seen in FIGURES 8 and 9 has an opening defined by its forked end and into which the end 114 of the support 110 fits. A bolt or Allen nut 107 passes through the openings provided in the connecting member 106 and the end 114 with the arrangement being such that the angle of the obturator axis with respect to the longitudinal axis of the support 110 is readily adjusted. When the desired angle has been established the bolt 107 is tightened so that a clamping action occurs between the legs of theconnector 106 and the end 114 to thereby prevent further undesired relative movement, between the obturator and the support. The adjustment of the obturator with respect to the support is further illustrated by the dashed lines of FIGURE 11.

A pointed and elongated surgical blade 120 shown as a Baud-Parker type blade is secured to a sliding handle 121. An adjustment screw 122 is threaded in the opening provided in the blade 120 with the end of the screw 122 being engaged with the exterior of the sliding handle 121. The handle 121 is in the form of a tubular member or cylinder disposed about the elongated support 110 and adapted for sliding movement with respect thereto; An elongated slot 121A provided in the sliding handle 121 encompasses the pin or set screw 123 secured to the sup,- port 110. The arrangement is such thatthe handle 121 slides in a longitudinal direction along the support 110 but is held against rotation with respect thereto. The

- operation of the apparatus is similar to that described with respect to the previous embodiment in that when the handle 121 is reciprocated along the support the blade undergoes a plunging action.

It will be seen from FIGURES 8-13 that the angle of the obturator with respect to the support 110 is readily adjusted by the bolt or Allen nut 107 to determine the depth to which the blade 120 goes before it contacts the obturator. Thus the length (or height) of the conical section can be accurately controlled. As seen most clearly in FIGURE 11, the angle of the blade 120 with respect to the support 110 is also readily adjusted by means of the adjustment screw 122. Thus the width of the base of the cone of tissue can also be accurately and easily controlled. As seen most clearly in FIGURE 13, the obturator 116 serves to deviate the mobile cervix to any selected angle with the blade then being actuated in a straight line such that a true conical section is obtained. As in the previous embodiment, and as seen in FIGURE 10, the blade 120 is not only pointed but also has a cutting edge 120A which is directed circumferentially with relation to the path of motion thereof generated by movement of the instrument around the axis of the obturator 16. In practice it will be seen from FIGURE 13 that the mobile cervix can be effectively translated in a generally circular path around the longitudinal axis of the blade 120 as the repeated plunging action takes place. As in the previously described operation of the embodiment of FIGURES 1-7, an incremental relative rotation between the cervix and the blade is made between each plunging movement of the blade so that substantially contiguously adjacent incisions are made. The process is repeated successively until a full circle of plunging incisions have been completed, and then the section removed in the above described manner.

It will be evident from the foregoing description that there is no danger of undercutting of the endocervical canal or of the adjoining tissue by operation of the instru ment inasmuch as the obturator 16 itself serves as a positive stopping or locating device preventing the blade from plunging across the canal and cutting into the tissue on the opposite side and into regions not intended to be severed with the biopsy section It is also evident that reliable referencing of the blade with relation to the relatively tough and mobile tissue of the uterine cervix is achieved in a positive manner so that a cone of uniform and symmetrical dimensions is obtained without injury to the surrounding tissue or vessels It is further evident that replacing the blade of the first embodiment with a blade of different curvature and by adjusting the radius arm upon which the blade swings, biopsy sections of any relative dimensions 7 may be obtained suited to the requirements of a particular diagnosis. Similarly, in the second embodiment the angle of the blade with respect to the handle axis as well as of the obturator with respect to the blade permits accurate control over specimen dimensions.

These and other features and aspects of the invention will be recognized by those skilled in this art.

I claim as my invention:

1. A surgical instrument for conization of the uterine cervix comprising an elongated obturator insertable lengthwise into the endocervical canal, stop means physically connected with the obturator in such relative position as to engage the endocervix and thereby limit penetration of the obturator, an elongated support having a handle end and a distal opposite end, which opposite end carries the obturator to effect such insertion thereof, an elongated cutting blade having a point adapted to pierce the cervix, and means including a blade carrier mounted on said support and guiding the blade to move generally lengthwise of itself and relative to the obturator between an extended position pressed inwardly and throuh the cervix tissue substantially to the cervical canal and a retracted position substantially withdrawn from the cervix.

2. The surgical instrument defined in claim 1, wherein the blade carrier comprises an arm pivoted on an axis transverse to the obturator and displaced from the axis of the obturator so as to direct the movement of the blade arcuately into incidence with the obturator at an acute angle.

3. The surgical instrument defined in claim 2, wherein the blade and cutting edge thereof are curved in substantial conformity to the arc of swing of the blade.

4. The surgical instrument defined in claim 2 and including an actuator on said support connected to said arm and moving said arm about said axis when said actuator is moved along said support.

5. The surgical instrument defined in claim 3, further comprising means permitting adjustment of the radius of swing of the blade on the arm.

6. The surgical instrument defined in claim 1 wherein said blade carrier is slidable along said support for moving the blade between said extended and retracted positions.

7. The surgical instrument defined in claim 6 wherein said blade carrier comprises a handle member slidably carried on said support for movement toward and away from said distal opposite end and having said blade directly connected thereto, and wherein said obturator is disposed at an angle with respect to the longitudinal axis of said elongated support.

8. The surgical instrument defined in claim 7 including means supporting said obturator on said distal opposite end of said support for selective adjustment of the angle between said obturator and said support.

9. The surgical instrument defined in claim 8 and including adjustment means engaged with said blade for adjusting the angle of said blade with respect to said obturator.

10. The surgical instrument defined in claim 9 wherein said adjustment means includes a settable adjustment member extending between said blade and said handle member for selective adjustment of the angle between said blade and said handle member.

11. The surgical instrument defined in claim 9 wherein said support includes a first elongated right cylinder, and said handle member includes a second elongated right cylinder disposed about said first cylinder and having said blade connected thereto.

12. A surgical instrument for conization of the uterine cervix comprising a cervix-engaging positional referencing means, an elongated support having a handle end and a distal opposite end, which latter carries the referencing means to bring the same into predetermined positional engagement with the endocervix, an elongated narrow cutting blade having a point adapted to pierce the cervix, a blade carrier mounted on said support and guiding the blade to move in relation to said referencing means along a path having a center of curvature displaced from the axis of said support between an extended position pressed inwardly and transversely through the cervix tissue substantially to the cervical canal, and a retracted position substantially withdrawn from the cervix, and actuator means on said support connected to the blade carrier for moving the blade between such positions.

13. The surgical instrument defined in claim 12, wherein the referencing means comprises an elongated shaft having a shoulder in fixed relation to the end of the shaft, said shaft being insertable into the cervical canal to a depth limited by the shoulder to guide the shaft for revolving and thereby the blade for revolving about an axis defined by the canal, so as to complete the severance of a conical section of tissue by the blade.

14. The surgical instrument defined in claim 12, where- 1n the blade carrier includes a support arm connected to said blade and means supporting said arm at a point displaced from the axis of said shaft, and said carrier guides the blade into limiting contact with the shaft in the blades extended position.

15 A surgical conization instrument for the uterine cervix comprising a guide element engageable with the uterine cervix to be guided thereby for permitting such element to be revolved about an axis substantially aligned With the cervical canal while being pressed into such engagement with the cervix, a support for said guide element including a handle portion projecting therefrom, a cut ting blade, means mounting said blade in normally retracted position ,on said support out of contact with the cervix and guiding the blade to permit relative advancement thereof through the endocervix along a plane of approach inclined to said axis and in a path having a center of curvature displaced from said axis and on the opposite side of said guide element from said blade, the blade having a cutting edge directed circumferentially of and substantially parallel to said axis, whereby re- 7 volving of the support, and thereby of the blade, severs a substantially conical section from the endocervix.

16. A surgical conization instrument for the uterine cervix comprising a positional reference element engageable with the uterine endocervix to be oriented lengthwise of the endocervix for defining an axis of revolution substantially aligned with the cervical canal, a. support for said reference element including a handle portion projecting therefrom, an elongated pointedcutting blade having a cutting edge directed circumferentially of and substantially parallel to said axis, means mounting said blade in normally retracted position on said support out of contact with the cervix and guiding the blade to permit relative advancement thereof through the endocervix along a plane of approach inclined to said axis, the blade having a cutting edge directed circumferentially in relation to said axis, whereby revolving of the support, and thereby of the blade, severs a substantially conical section from the endocervix.

17. A surgical instrument for conization of the uterine cervix comprising an elongated obturator insertable lengthwise into the cndocervical canal, stop means physically connected with the obturator in such relative position as to engage the endocervix and thereby limit penetration of the obturator, an elongated support having a handle end and a distal opposite end, which latter carries the obturator to effect such insertion thereof, an elongated cutting blade, a blade carrier mounted on said support and guiding the blade to move generally lengthwise of itself between an extended position pressed inwardly and transversely through the cervix tissue substantially to the cervical canal, and a retracted position substantially withdrawn from the cervix, and actuator means on said support connected to the blade carrier for moving the blade between such positions, said blade carrier comprising an arm pivoted on an axis transverse to and displaced from the obturator such that the axis and said blade are on diametrically opposed sides of the obturator so as to direct the movement of the blade arcuately into incidence with the obturator at an acute angle, said actuator means comprising a plunger guided on the support for movement lengthwise thereof, and linkage means interconnecting the plunger and the arm.

18. The instrument defined in claim 17, and spring means reacting between the support and plunger urging the latter in a relative direction to urge the blade toward its retracted position.

References Cited UNITED STATES PATENTS 1,127,948 2/ 1915 Wappler 1283 11 X 2,730,101 1/1956 Hoffman 128-305 2,839,051 6/1958 Chester 1282 2,945 ,490 7/ 1960 Westcott 1282 3,147,749 8/1964 Marsh 128-2 RICHARD A. GAUDET, Primary Examiner.

SIMON BRODER, Examiner. 

1. A SURGICAL INSTRUMENT FOR CONIZATION OF THE UTERINE CERVIX COMPRISING AN ELONGATED OBTURATOR INSERTABLE LENGTHWISE INTO THE ENDOCERVICAL CANAL, STOP MEANS PHYSICALLY CONNECTED WITH THE OBTURATOR IN SUCH RELATIVE POSITION AS TO ENGAGE THE ENDOCERVIX AND THEREBY LIMIT PENETRATION OF THE OBTURATOR, AN ELONGATED SUPPORT HAVING A HANDLE END AND A DISTAL OPPOSITE END, WHICH OPPOSITE END CARRIES THE OBTURATOR TO EFFECT SUCH INSERTION THEREOF, AN ELONGATED CUTTING BLADE HAVING A POINT ADAPTED TO PIERCE THE CERVIX, AND MEANS INCLUDING A BLADE CARRIER MOUNTED ON SAID SUPPORT AND GUIDING THE BLADE TO MOVE GENERALLY LENGTHWISE OF ITSELF AND RELATIVE TO THE OBTURATOR BETWEEN AN EXTENDED POSITION PRESSED INWARDLY AND THROUGH THE CERVIX TISSUE SUBSTANTIALLY TO THE CERVICAL CANAL AND A RETRACTED POSITION SUBSTANTIALLY WITHDRAWN FROM THE CERVIX. 